Atlas FDA

OWN

62 FDA 510(k) clearances · Product code

91 daysmedian time to decision
267 days90th percentile
62clearances measured

FDA profile

Official device name
Confocal Optical Imaging
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
FDA definition
Collection of light signals for visualization of cellular microstructures.
Adverse events (MAUDE)
2021: 312 · 2022: 346 · 2023: 164 · 2024: 165 · 2025: 197 · 2026: 149
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
PerfusiX-Imaging (K254180)LIMIS Development B.V.2026-07-24
SmartSurgN Visualization System (K242163)SmartsurgN, Inc.2026-04-20
KARL STORZ ICG Imaging System with RUBINA® Lens (K254242)Karl Storz SE & CO. KG2026-02-26
cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) (K251852)VPIX Medical, Inc.2026-02-13
IMAGE1 (TC400US); X-to-4U Adapter (TC040) (K253972)Karl Storz SE & CO. KG2026-02-12
L12 LED Light Source with AIM (K260108)Stryker Endoscopy2026-02-12
VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) (K251336)Olympus Medical Systems Corp.2025-11-12
Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); (K243711)Wuxi Hisky Medical Technologies Co., Ltd.2025-07-24
OPTOVISION Endoscopic Light Source Unit (K243591)Optosurgical, LLC2025-02-19
Histolog® Scanner (Hardware 2.4, Software 3.3) (K241275)Samantree Medical SA2024-08-19
KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit (K233333)Karl Storz SE & CO. KG2023-11-21
KARL STORZ ICG Imaging System (K232857)Karl Storz SE & CO. KG2023-11-06
1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM (K231854)Stryker2023-09-20
ActivSight Intraoperative Imaging System (K231344)Activ Surgical, Inc.2023-08-02
FloNavi Open Field Fluorescence Imaging System (K230407)Guangdong Optomedic Technologies, Inc.2023-07-17
L12 LED Light Source with AIM (K230754)Stryker2023-04-11
SmartSurgN Visualization System (K213943)Smartsurgn Incorporated2022-11-29
VS3-Iridium System (VS3-IR) (K223020)Visionsense, Ltd.2022-10-28
780 nm L11 LED Light Source with AIM (K221611)Stryker2022-06-29
Cellvizio 100 series system with confocal Miniprobes (K220477)Mauna Kea Technologies2022-04-11
VS3 Iridium Sytem (K210265)Visionsense, Ltd.2021-11-22
KARL STORZ ICG Imaging System (K212695)Karl Storz Endoscopy America2021-11-15
Cellvizio I.V.E. system with Confocal Miniprobes (K212322)Mauna Kea Technologies2021-08-18
ActivSight Intraoperative Imaging System (K203550)Activ Surgical, Inc.2021-04-08
KARL STORZ ICG Imaging System (K202925)Karl Storz Endoscopy_America, Inc.2020-12-17
SPY-PHI System with SPY-PHI Fluorescence Assessment Software (K202244)Novadaq Technologies Ulc. (Now A Part of Stryker)2020-11-05
HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head (K201399)Karl Storz-Endoscopy-America, Inc.2020-08-17
Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head (K200542)Olympus Medical Systems Corp.2020-07-17
SPY Portable Handheld Imaging (SPY-PHI) System (K200737)Novadaq Technologies Ulc. (Now A Part of Stryker)2020-05-21
Cellvizio I.V.E. with Confocal Miniprobes (K193416)Mauna Kea Technologies2020-02-28
Cellvizio 100 Series System with Confocal Miniprobes (K191144)Mauna Kea Technologies2020-01-24
VS3-IR (K191851)Medtronic2019-11-25
L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable (K192292)Stryker2019-11-19
SPY Portable Handheld Imaging (SPY-PHI) System (K192174)Novadaq Technologies Ulc. (Now A Part of Stryker)2019-11-15
L10 LED Light Source with AIM, L11 LED Light Source with AIM (K191046)Stryker2019-05-10
SPY Portable Handheld Imaging (SPY-PHI) System (K190729)Novadaq Technologies Ulc. (Now A Part of Stryker)2019-04-19
VS3-IR (K183453)Medtronic2019-03-04
Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes (K183640)Mauna Kea Technologies2019-02-22
Stryker AIM Light Source and SafeLight cable (K173866)Stryker2018-01-18
Cellvizio 100 Series System with Confocal Miniprobes (K172844)Mauna Kea Technologies2017-12-15
Cellvizio 100 Series Systems with Confocal Miniprobes (K171345)Mauna Kea Technologies2017-08-04
KARL STORZ ICG Imaging System (K171238)KARL STORZ Endoscopy-America, Inc.2017-05-25
KARL STORZ ICG Imaging System (K162882)KARL STORZ Endoscopy-America, Inc.2017-01-26
SPY Phi Open Field Handheld Fluorescence Imaging System (K162885)Novadaq Technologies, Inc.2017-01-11
KARL STORZ Endoscopic ICG Imaging System (K152583)KARL STORZ Endoscopy-America, Inc.2016-05-31
CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes (K160416)Mauna Kea Technologies2016-05-20
Cellvizio 100 Series System with Confocal Miniprobes (K150831)Mauna Kea Technologies2015-12-22
VS3-IR system (K152204)Visionsense, Ltd.2015-10-28
Cellvizio 100 Series System with Confocal Miniprobes (K151593)Mauna Kea Technologies2015-10-23
Artemis Hand Held Imaging System (K143474)Quest Medical Imaging2015-06-30
VS3-IR-MMS System (K150018)Visionsense, Ltd.2015-06-17
Stryker Infrared Fluorescence (IRF) Imaging System (K142310)Stryker Endoscopy2014-12-02
CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES (K141358)Mauna Kea Technologies2014-09-25
CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM) (K133466)Mauna Kea Technologies2014-07-25
FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM (K132475)Fluoptics2014-05-07
CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED (K132389)Daniel & Daniel Consulting2014-02-25
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM (K124031)Intuitive Surgical, Inc.2013-09-13
CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES (K123676)Mauna Kea Technologies2013-04-18
CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES (K122042)Mauna Kea Technologies2012-09-04
CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES (K120208)Mauna Kea Technologies2012-04-20
PDE PHOTODYNAMIC EYE (K110480)Hamamatsu Photonics K.K.2012-01-13
CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (K111047)Mauna Kea Technologies, Inc.2011-08-08

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Every clearance here is in the API, with alerts when new ones post.